KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
226 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Head and neck squamous cell cancer (HNSCC)
KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumours express PD-L1 with a CPS ≥1, as determined by a validated test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.